(90 days)
Not Found
No
The description focuses on established hematology analysis techniques (impedance, light scatter, conductivity) and does not mention AI or ML. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No
The device is described as an "In Vitro Diagnostic Use" hematology analyzer, which means it analyzes samples (like blood) outside of the body to provide diagnostic information, rather than directly treating a patient.
Yes
The device is described as "For In Vitro Diagnostic Use in clinical laboratories", which signifies its role in diagnosing diseases or conditions. It provides "quantitative, automated hematology analysis and leukocyte differential counting", and "automated Reticulocyte analysis", all of which are diagnostic functions.
No
The device description clearly details hardware components and physical processes (impedance measurement, flow cell analysis, laser light, supravital dye incubation, clearing reagent) used for analyzing blood samples. It is an automated hematology analyzer, which is a physical device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement in Intended Use: The "Intended Use / Indications for Use" section clearly states: "For In Vitro Diagnostic Use in clinical laboratories."
- Nature of the Device: The device is a hematology analyzer that performs quantitative measurements and differential counting of blood cells. This type of analysis is performed on biological samples (blood) in vitro (outside the body) to provide information for diagnostic purposes.
- Clinical Laboratory Setting: The intended user and care setting is "clinical laboratories," which is a typical environment for IVD devices.
The description of the device's function (analyzing blood cells using impedance, light scatter, and dye) further confirms its role in performing diagnostic tests on biological samples.
N/A
Intended Use / Indications for Use
The COULTER® GEN-S system is a quantitative, automated hematology analyzer and leukocyte differential counter For In Vitro Diagnostic Use in clinical laboratories. The GEN-S System also provides automated Reticulocyte analysis. The COULTER GEN-S SMM INTEGRATED SLIDEMAKER Option prepares a blood film on a clean microscope slide.
The GEN S System has the same intended use as the predicate device the same hematological parameters. Both systems utilize the Coulter principle for enumeration and sizing of blood cells, in combination with automatic diluting and mixing for sample processing and a beam photometry. The same reagent system is used consisting of an isotonic diluent, lytic reagents and instrument cleaner. Both systems measure Reticulocytes utilizing New Methylene Blue. For reticulocyte analysis on the GEN-S System, a portion of aspirated sample is used for on-line preparation. Sample preparation for reticulocyte analysis on the STKS Analyzer is done off-line.
Product codes
864.5220, 864.5850
Device Description
The product is an Automated Differential Cell Counter which like the predicate device COULTER® STKS Analyzer with Reticulocyte Analysis uses the Coulter method of impedance measurement for particle counting and sizing. Blood cells passing through a small opening simultaneously with an electric current cause an impedance change in the orifice. This electrical pulse can be sized and counted. While the number of pulses indicates particle count, the size of the electrical pulse is proportional to the cell volume.
WBC differential analysis and classification occurs in the flow cell where low-frequency current measures volume, highfrequency current senses cellular internal content, and light from the laser bouncing off the individual WBC cells characterizes cellular surface, shape and reflectivity.
To measure the number of Reticulocytes in the sample, a supravital dye, is incubated with whole blood samples. The dye precipitates the basophilic RNA network found in reticulocytes. Hemoglobin and unbound stain are removed by adding a clearing reagent, leaving clear spherical mature RBCs and darkly stained reticulocytes. Stained Reticulocytes are differentiated from mature red cells and other cell populations by light scatter, direct current measurements and opacity characteristics when using the GEN-S with volume, conductivity, light scatter and reticulocyte counting technology.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
clinical laboratories.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Testing included in this submission focuses on attributes of precision, accuracy, linearity and carryover. Testing met all acceptance criteria.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 864.5200 Automated cell counter.
(a)
Identification. An automated cell counter is a fully-automated or semi-automated device used to count red blood cells, white blood cells, or blood platelets using a sample of the patient's peripheral blood (blood circulating in one of the body's extremities, such as the arm). These devices may also measure hemoglobin or hematocrit and may also calculate or measure one or more of the red cell indices (the erythrocyte mean corpuscular volume, the mean corpuscular hemoglobin, or the mean corpuscular hemoglobin concentration). These devices may use either an electronic particle counting method or an optical counting method.(b)
Classification. Class II (performance standards).
0
OCT 30 pc
510(k) Summary COULTER® GEN-STM System
| Date of Summary: | July 30, 1996 |
|---|---|
| Company/Institution name: | Coulter Corporation, |
| 11800 SW 147 Ave. | |
| Miami, FL 33196, Mailcode 31-B06 | |
| Contact Name: | Thomas J. English, Phone 1-305-380-4331 |
| Common or usual name or classification name: | Automated Differential Cell Counter |
| Product name: | COULTER® GEN-S™ System |
| C.F.R. Section: | 864.5220 |
| Device Class: | Class II |
| Optional Device Name: | COULTER GEN-S SM™ INTEGRATED SLIDEMAKER Option |
| C.F.R. Section: | 864.5850 |
| Device Class: | Class I, Exempt |
510(k) numbers of Coulter devices to which substantial equivalence is claimed: COULTER® STKS Analyzer with Reticulocyte Analysis, K885093 and K932030
The product is an Automated Differential Cell Counter which like the predicate device COULTER® STKS Analyzer with Reticulocyte Analysis uses the Coulter method of impedance measurement for particle counting and sizing. Blood cells passing through a small opening simultaneously with an electric current cause an impedance change in the orifice. This electrical pulse can be sized and counted. While the number of pulses indicates particle count, the size of the electrical pulse is proportional to the cell volume.
WBC differential analysis and classification occurs in the flow cell where low-frequency current measures volume, highfrequency current senses cellular internal content, and light from the laser bouncing off the individual WBC cells characterizes cellular surface, shape and reflectivity.
To measure the number of Reticulocytes in the sample, a supravital dye, is incubated with whole blood samples. The dye precipitates the basophilic RNA network found in reticulocytes. Hemoglobin and unbound stain are removed by adding a clearing reagent, leaving clear spherical mature RBCs and darkly stained reticulocytes. Stained Reticulocytes are differentiated from mature red cells and other cell populations by light scatter, direct current measurements and opacity characteristics when using the GEN-S with volume, conductivity, light scatter and reticulocyte counting technology.
Intended Use: The COULTER® GEN-S system is a quantitative, automated hematology analyzer and leukocyte differential counter For In Vitro Diagnostic Use in clinical laboratories. The GEN-S System also provides automated Reticulocyte analysis. The COULTER GEN-S SMM INTEGRATED SLIDEMAKER Option prepares a blood film on a clean microscope slide.
The GEN S System has the same intended use as the predicate device the same hematological parameters. Both systems utilize the Coulter principle for enumeration and sizing of blood cells, in combination with automatic diluting and mixing for sample processing and a beam photometry. The same reagent system is used consisting of an isotonic diluent, lytic reagents and instrument cleaner. Both systems measure Reticulocytes utilizing New Methylene Blue. For reticulocyte analysis on the GEN-S System, a portion of aspirated sample is used for on-line preparation. Sample preparation for reticulocyte analysis on the STKS Analyzer is done off-line.
Testing included in this submission focuses on attributes of precision, accuracy, linearity and carryover. Testing met all acceptance criteria.
- h)
1
Not applicable for this submission. i)
.
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